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CQV Engineer

1 month ago

Westfield, United States Vitalent Full time
ViTalent is a premier professional services organization specializing in talent acquisition, talent development, staffing, and consulting for Life Sciences. Our business is people Talent is in high demand, and our simple mission is to impact lives as a long-term partner for both talent and organizations.

ViTalent is currently seeking CQV Engineers with experience in large CapEx projects or greenfield facilities in cGMP environments to support key projects in the greater Indianapolis area.

Description
  • Provide technical CQV (commissioning, qualification, and verification) expertise on large capital projects involving new or modified equipment, facilities, and utilities ensuring CQV aspects are delivered consistently and efficiently. Includes authoring and executing documents such as URS, System Boundary Definition, Risk Assessment, Traceability Matrices, Design Qualification, Start Up and Debug documentation, commissioning documents, including FAT and SAT, IQ/OQ/PQ, and Turnover documentation.
  • Support technical commissioning and qualification documentation for complex, automated equipment, and processes, in accordance with client's quality standards, current Good Manufacturing Practices, (21 Code of Federal Regulations Part 210, 211 and 820 level standards which apply to the equipment and product being validated) and national/international standards.
  • Verify system drawings including ability to review and as-build P&IDs and I&C drawings as well as verifying electrical schematics with electrical engineering support.
  • Manage and work collaboratively with clients' quality representative to complete deviation investigation and resolution for problems and issues encountered during execution activities. Maintain clear and detailed records of qualification and change control activities for future compliance audits.
  • Project assignments will vary by customer requirements for specific defined deliverables based on project needs and scope.

Qualifications:
  • Bachelor's degree or equivalent required (STEM degree preferred).
  • Applicants must be authorized to work for any employer in the United States without visa sponsorship. ViTalent is unable to sponsor or take over sponsorship of an employment visa.
  • 3+ years of experience in commissioning, qualification, and validation in a regulated industry (pharmaceutical, biotechnology, medical device, etc.).
  • Experience working on large greenfield or expansion CapEx projects in pharma and biotech manufacturing
  • Strong, proven knowledge of Good Manufacturing and Good Documentation Practices
  • Knowledge of relevant regulatory requirements (e.g., FDA, EMA, cGMP).
  • Strong analytical and problem-solving skills.
  • Excellent written and verbal communication skills.
  • Ability to work independently and as part of a team.
  • Proficiency in using validation software and tools is a plus.
  • Experience with automation and computerized systems validation.
  • Familiarity with Lean or Six Sigma methodologies.

Responsibilities:
  1. Commissioning:
    • Develop and execute commissioning plans for new and existing equipment and systems.
    • Collaborate with project teams to ensure equipment is installed and operates according to design specifications.
    • Perform functional testing and troubleshoot issues during the commissioning phase.
  2. Qualification:
    • Develop and execute qualification protocols (IQ/OQ/PQ) for equipment, utilities, and systems. Conduct FAT and SAT .
    • Conduct risk assessments and identify critical process parameters.
    • Ensure compliance with regulatory standards and company policies during the qualification process.
  3. Validation:
    • Develop and implement validation master plans for processes, cleaning, and computerized systems.
    • Perform validation activities, including process validation, cleaning validation, and computer system validation.
    • Document validation findings and provide recommendations for improvements.
  4. Documentation and Compliance:
    • Prepare detailed reports and documentation for commissioning, qualification, and validation activities.
    • Ensure all documentation meets regulatory and company standards.
    • Stay updated on industry regulations, guidelines, and best practices.
  5. Collaboration and Communication:
    • Work closely with cross-functional teams, including quality assurance, engineering, production, and regulatory affairs.
    • Communicate effectively with internal and external stakeholders to ensure alignment on project objectives and timelines.

If you meet the qualifications and are interested in this opportunity, please submit your resume immediately. We look forward to getting to know you as you consider the next steps in your career.

All applicants will be considered for employment without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran, or disability status.

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